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    Summary
    EudraCT Number:2019-003751-10
    Sponsor's Protocol Code Number:DRI15103
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003751-10
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and tolerability of SAR440340 (anti-IL-33 mAb) in patients with moderate-to-severe asthma
    Studio randomizzato, in doppio cieco, controllato con placebo, dose-ranging per valutare l’efficacia, la sicurezza e la tollerabilità di SAR440340 (mAb anti-IL-33) in pazienti affetti da asma da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dose-ranging study to assess the efficacy, safety, and tolerability of SAR440340 (anti-IL-33 mAb) in patients with moderate-to-severe asthma
    Studio di dose-ranging per valutare l’efficacia, la sicurezza e la tollerabilità di SAR440340 (mAb anti-IL-33) in pazienti con asma da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numberDRI15103
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1228-9151
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi-Aventis Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name.
    D.3.2Product code [SAR440340]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeSAR440340
    D.3.9.3Other descriptive nameREGN3500
    D.3.9.4EV Substance CodeSUB182669
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of different SAR440340 regimens on forced expiratory volume in 1 second (FEV1) in patients with moderate - to severe asthma
    Valutare l’efficacia dei diversi regimi posologici con SAR440340 sul volume espiratorio forzato in 1 secondo (FEV1) in pazienti con asma da moderata a grave
    E.2.2Secondary objectives of the trial
    -Evaluate the efficacy of different SAR440340 regimens compared with placebo on the overall rate of severe asthma exacerbations
    -Evaluate the efficacy of different SAR440340 regimens compared with placebo on FEV1
    -Evaluate the efficacy of different SAR440340 regimens compared to placebo on other asthma exacerbation parameters
    -Evaluate the efficacy of different SAR440340 regimens compared to placebo on other lung function measurements
    -Evaluate the efficacy of different SAR440340 regimens compared to placebo on asthma control
    -Evaluate the efficacy of different SAR440340 regimens compared to placebo on asthma symptoms
    -Evaluate the efficacy of different SAR440340 regimens compared to placebo on quality of life
    -Evaluate the safety and tolerability of different SAR440340 regimens compared to placebo
    -Evaluate the pharmacokinetic (PK) profile of different SAR440340 regimens
    -Evaluate immunogenicity of different SAR440340 regimens.
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo sul tasso compless di riacutiz asmatiche gravi
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo su FEV1
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo su altri parametri di riacutiz asma
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo su altre misuraz della funzione polmonare
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo sul controllo asma
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo sui sintomi asma
    - Valut l’efficacia dei diversi regimi posologici con SAR440340 rispetto a placebo sulla QoL
    - Valut la sicurezza e la tollerabilità dei diversi regimi posologici con SAR440340 rispetto a placebo
    - Valut il profilo PK dei diversi regimi posologici con SAR440340
    - Valut l’immunogenicità dei diversi regimi posologici con SAR440340
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be >/= 18 to </= 75 years of age inclusive (or the minimum legal age for majority in the country of the investigational site).
    -Adult participants with a physician diagnosis of asthma for at least 12 months prior to screening (Visit 1) based on the Global Initiative for Asthma (GINA) 2019 Guidelines.
    -Existing treatment with medium to high dose ICS (>/=500 mcg of fluticasone propionate daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a LABA. Up to two additional controller medications are allowed (LAMA and/or LTRA). Current treatment should be initiated at least 3 months prior to Visit 1 and should be stable >/=1 month prior to Visit 1.
    -Pre-bronchodilator forced expiratory volume (FEV1) >/=40% and </=80% of predicted normal at Visits 1 and 2, prior to randomization.
    -Asthma Control Questionnaire 5-question version (ACQ-5) score >/=1.5 at Visits 1 and 2, prior to randomization.
    -Patients with reversibility of at least 12% and 200 mL in FEV1 after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening.
    -Must have experienced, within 1 year prior to Visit 1, any of the following events:
    • At least two episodes of treatment with a systemic steroid (oral or parenteral) for worsening asthma;
    OR
    • One episode of hospitalization for worsening asthma.
    -Capable of giving signed informed consent.
    Il partecipante deve avere un’età compresa tra >/=18 anni e </= 75 anni (o l’età minima legale per la maggiore età nel Paese del centro sperimentale)
    Partecipanti adulti con diagnosi di asma formulata da un medico da almeno 12 mesi prima dello screening (Visita 1) in base alle linee guida 2019 dell’Iniziativa globale per l’asma (GINA)
    Trattamento esistente con ICS a dosaggio medio-alto (>/=500 mcg di fluticasone propionato al giorno o dosaggio giornaliero ICS equipotente fino a un massimo di 2000 mcg/giorno di fluticasone propionato o equivalente) in combinazione con un LABA. Sono consentiti fino a due ulteriori farmaci per il controllo dell’asma (LAMA e/o LTRA). Il trattamento attuale deve essere iniziato almeno 3 mesi prima della Visita 1 e deve essere stabile per >/= un mese prima della Visita 1
    Volume espiratorio forzato (FEV1) pre-broncodilatatore >/= 40% e </= 80% del normale previsto alle Visite 1 e 2, prima della randomizzazione.
    Punteggio >/= 1,5 nel questionario sul controllo dell’asma, versione con 5 domande (ACQ-5) durante le visite 1 e 2 prima della randomizzazione
    Pazienti con reversibilità almeno del 12% e che riportano 200 ml nel FEV1 dopo la somministrazione di 2-4 inalazioni (200-400 mcg) di albuterolo/salbutamolo o levalbuterolo/levosalbutamolo durante lo screening.
    Evenienza, nell’arco di 1 anno prima della Visita 1, di uno qualsiasi dei seguenti eventi:
    • almeno due episodi di trattamento con uno steroide sistemico (per via orale o parenterale) a causa del peggioramento dell’asma;
    OPPURE
    • un episodio di ricovero per un peggioramento dell’asma.
    Partecipanti in grado di fornire un consenso informato firmato
    E.4Principal exclusion criteria
    -Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibro-sis, etc) which may impair lung function or another diagnosed pulmonary or systemic disease.
    -Either clinical or imaging (Chest X-ray, CT, MRI) evidence of lung disease(s) other than asthma within 12 months of Visit 1.
    -A subject who experiences a severe asthma exacerbation at any time from 4 weeks prior to the Screening (Visit 1) up to and including the Baseline Visit (Visit 2).
    -History of life threatening asthma in past 1 year prior to screening.
    -Current smoker or cessation of smoking within 6 months prior to Visit 1. Current vaping or cessation of vaping within 6 months prior to Visit 1 is also not allowed.
    -A patient with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder.
    -Patients with a history of a systemic hypersensitivity reaction to a monoclonal antibody.
    -Anti-IgE therapy within 130 days prior to Visit 1 or any other biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease and other diseases, within 2 months or 5 halflives prior to Visit 1, whichever is longer.
    Broncopneumopatia cronica ostruttiva (BPCO) o altre malattie polmonari (ad es. fibrosi polmonare idiopatica, ecc.) che possono compromettere la funzione polmonare o un’altra malattia polmonare o sistemica diagnosticata.
    Evidenza clinica o di diagnostica per immagini (radiografia toracica, TC, RM) di malattia/e polmonare/e diversa/e dall’asma entro 12 mesi dalla Visita 1.
    Soggetto che manifesta una grave riacutizzazione dell’asma in qualsiasi momento dalle 4 settimane precedenti lo screening (Visita 1) fino alla Visita basale (Visita 2).
    Anamnesi di asma potenzialmente letale nell’ultimo 1 anno prima dello screening
    Attuale fumatore o rinuncia al fumo avvenuta nei 6 mesi precedenti la Visita 1. Non sono inoltre consentiti l’uso della sigaretta elettronica e la sua cessazione nei 6 mesi precedenti la Visita 1.
    Paziente con anamnesi di patologia o disturbo clinicamente significativo renale, epatico, cardiovascolare, metabolico, neurologico, ematologico, oftalmologico, respiratorio, gastrointestinale, cerebrovascolare o altre malattie o disturbi medici significativi
    Pazienti con anamnesi di reazione sistemica da ipersensibilità a un anticorpo monoclonale
    Terapia anti-IgE entro 130 giorni prima della visita 1 o di qualsiasi altra terapia biologica o immunosoppressore sistemico per il trattamento di malattie infiammatorie o autoimmuni e altre malattie, entro 2 mesi o 5 vite prima della visita 1, a seconda di quale sia più lunga.
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change from baseline in FEV1 (prebronchodilator) ; Absolute change from baseline in FEV1 (prebronchodilator) at week 24 in the intent-to treat (ITT) population with baseline blood eosinophil count >/= 300 cells/mm^3
    Variazione assoluta rispetto al basale del FEV1 (pre-broncodilatatore) : Variazione assoluta rispetto al basale del FEV1 (pre-broncodilatatore) alla Settimana 24 nella popolazione ITT con conta basale degli eosinofili nel sangue >/=300 cellule/mm3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 24
    DAL BASALE ALLA SETTIMANA 24
    E.5.2Secondary end point(s)
    1-Annualized rate of severe asthma exacerbs over 24 to 48- wk placebo-controlled treatm period in ITT pop and in ITT pop with basel blood eosinophil count>/=300 cells/mm3;A severe asthma exacerb event during the study is defined as deterioration of asthma requiring:Use of systemic corticost for>/=3days or Hospital or emergency room visit because of asthma,requiring systemic corticost
    2-Time to first severe asthma exacerb during 24 to 48-wk PC treatm period;A severe asthma exacerb event during study is defined as deterioration of asthma requiring:Use of systemic corticost for>/=3days or Hospital or emergency room visit because of asthma,requiring systemic corticost
    3-Absolute chng from basel in FEV1(prebronchodilator)at wk 24 in ITT pop
    4- Percent chng from basel in FEV1(prebronchodilator)at wk 24 in ITT pop
    5- Annualized rate of LOAC event during 24 to 48-wk PC treatm period LOAC event during the treatm period is deterioration of asthma defined as any of the following:
    - A30% or greater reduction from basel in morning peak exploratory flow on 2 consecutive days
    - >/=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to basel) on 2 consecutive days
    -Severe asthma exacerb
    6-Time to first LOAC event during 24 to 48- wk PC treatm period
    7-Absolute and Percent chng from basel in pre-bronchodilator FEV1 at wks 4,8,12,16,20,28,32,36,40,44,48
    8-Absolute and Percent chng from basel in post-bronchodilator FEV1 at wks 4,12,24,48
    9-Chng from basel in forced expiratory flow 25-75%,Chng from basel in % predicted FEV1, Chng from basel in forced vital capacity, Chng from basel in morning peak expiratory flow at wks 4,8,24,48
    10-Chng from basel in total scores and individual domain scores in ACQ-5 at wks 4,12,24,36,48.ACQ was designed to measure both adequacy of asthma control and chng in asthma control which occurs either spontaneously or as a result of treatm.ACQ-5 is composed of the 5 items that assess the most common asthma symptoms
    11-Chng from basel in number of inhalations/day of salbutamol/albuterol or levosalbutamol/levalbuterol for symptom relief at wks4,12,24,36,48
    12-Chng from basel in nocturnal awakenings at wks4,12,24,36,48
    13-Chng from basel in ADSD score at wks4,12,24,36,48.The ADSD/ANSD have been designed to measure asthma symptoms in adult and adolescent(12 years of age and older)patients diagnosed with mild to severe asthma. ADSD is composed of 6 items and has an 11-point numeric rating scale
    14-Chng from basel in ANSD score at wks 4,12,24,36,48. ANSD is composed of 6 items and have an 11-point numeric rating scale
    15-PGIC in asthma symptoms at wk48(or EOT).PGIC is single item questionnaire that asks patients to provide overall self-assessment of chng of asthma symptom severity
    16-PGIS of asthma symptoms at wk48(or EOT).PGIS is one-item questionnaire that asks patients to provide overall self-assessment of asthma symptom severity
    17-Chng from basel in AQLQ[S] Self-Administered(>/=12 years)domain scores and total scores at wks12,24,48. AQLQ(S) has 32 items distributed in 4 domains:Symptoms(12items),Activity limitation(11items),Emotional function(5items),Environmental stimuli(4items).Individual items are equally weighted.Each item is rated on 7-point Likert scale from 1 to 7(1=severely impaired;7=not impaired at all)
    18-Chng from basel in SGRQ at wkjs24,48. SGRQ is 50-item designed to measure and quantify health status in adult patients with chronic airflow limitation.
    19-Safety;Incidence of Treatm-emergent AE and SAE;Incidence of Potentially clinically significant lab abnormalities in treatm-emergent period
    20-PK; Functional SAR440340 concentrations in serum from basel to end study
    21-Immunogen;Incidence of treatm-emergent anti-SAR440340 Ab responses and titer over time
    1- Tasso annualizz di riacutizz gravi asma nel periodo di tratt controllato con placebo di 24-48 sett in popolaz ITT e in popolaz ITT con conta basale eosinofili in sangue>/=300 cellule/mm3.una grave riacutizz asma durante lo studio è deterioram asma che richiede:uso di corticost sistemici per>/=3 gg o ricovero ospedal o visita a PS a causa di asma che richiede la somministraz di corticost sistemici
    2- Tempo a prima riacutizz grave di asma durante il periodo di tratt controllato con placebo di 24-48 sett. Una grave riacutizz di asma durante lo studio è deterioram di asma che richiede:uso di corticost sistemici per>/=3 giorni o ricovero ospedal o visita a PS a causa di asma che richiede la somministraz di corticost sistemici
    3- Variaz assoluta rispetto al basale di FEV1(pre-broncodilat)alla Sett24 in popolaz ITT
    4- Variaz percent di FEV1(pre-broncodilat)alla Sett24 in popolaz ITT
    5- Percent annualizz di eventi di LOAC durante il periodo di tratt controllato con placebo di24-48 sett.LOAC è deterioram asma:
    - Riduz 30% o superiore rispetto al basale di PEF mattutino in 2 gg consecutivi
    - >/=6 inalazioni aggiuntive di salbutam/albuter o levosalbutam/levalbuter, in un periodo di 24 ore (rispetto al basale) per 2 gg consecutivi
    - Grave riacutizz asma
    6- Tempo al primo evento di LOAC durante periodo di tratt controllato con placebo di 24-48 sett
    7- Variaz assoluta e percent rispetto a basale di FEV1 pre-broncodilat alle sett 4,8,12,16,20,28,32,36,40,44,48
    8- Variaz assoluta e percent rispetto al basale del FEV1 post-broncodilat alle sett 4,12,24,48
    9- Variaz rispetto al basale di FEF del 25-75%, Variaz in % rispetto al basale di FEV1, Variaz rispetto al basale di FVC, Variaz rispetto al basale di PEF mattutino alle sett 4,8,24,48
    10- Variaz rispetto al basale dei punteggi totali e dei punteggi di ogni dominio nel quest ACQ-5 alle sett4,12,24,36,48.ACQ è disegnato per misurare l'adeguatezza del controllo dell'asma e il cambiam nel controllo dell'asma che si verifica spontaneam o come risultato del tratt.CQ-5 è composto dai 5 elem che valutano i sintomi più comuni diasma
    11- Variaz rispetto al basale del N di inalaz/gg di salbutam/albuter o levosalbutam/levalbuter per sollievo dei sintomi alle sett4,12,24,36,48
    12- Variaz rispetto al basale dei risvegli notturni alle sett4,12,24,36,48
    13- Variaz rispetto al basale di ADSD alle sett4,12,24,36,48.ADSD/ANSD è stato disegnato per misurare i sintomi dell'asma in adulti e adolescenti(12 anni e più) con diagnosi di asma da lieve a grave.ADSD è composto da 6 elem e ha una scala di valutaz numerica a 11 punti.
    14- Variaz rispetto al basale di ANSD alle sett4,12,24,36,48.ANSD è composto da 6 elem e ha una scala di valutaz numerica di 11 punti
    15- PGIC sui sintomi dell’asma a Sett 48(o EOT).PGIC è questionario a elemento singolo che chiede ai pts di fornire l'autovalutaz generale del cambiamento della gravità dei sintomi dell'asma.
    16- PGIC sui sintomi dell’asma a Sett 48(o EOT).PGIS è questionario di un elem che chiede ai pts di fornire l'autovalutaz complessiva della gravità dei sintomi dell'asma
    17- Variaz dal basale dei punteggi di dominio in AQLQ [S] autosommin(>/=12aa)e punteggi totali alle sett 12,24,48.AQLQ(S) ha 32 elem distribuiti in 4 domini:Sintomi (12 elem),Limitazione attività (11 elem), Funzione emotiva(5 elem),Stimoli ambientali (4 elem).I singoli elem sono ugualm ponderati.
    18- Ogni elem è valutato su scala Likert a 7 punti da 1 a 7 (1-gravemente compromessa;7-non alterata affatto).
    19- Variaz rispetto al basale di SGRQ alle sett24,48.SGQR è quest di 50 elem disegnato per misurare e quantificare lo stato di salute nei pts adulti con limitaz cronica del flusso d'aria.
    20- Sicurezza:Incidenza di TEAE/SAE.Incidenza delle anomalie di lab potenz clinic significative nel periodo emergente dal tratt
    21- PK:Concentraz funz di SAR440340 nel siero dal basale alla fine dello studio
    22- Immunogenic:Incidenza risposte anticorpali anti-SAR440340 emergenti dal tratt e del titolo nel tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,5,6 : Baseline throughout week 24 -48
    3,4 : Baseline to week 24
    7 : Baseline to week 4, 8, 12, 16, 20, 28, 32, 36, 40, 44 and 48
    8 : Baseline to week 4, 12, 24 and 48
    9 : Baseline to week 4, 8, 24 and 48
    10, 11, 12, 13, 14 : Baseline to week 4, 12, 24, 36 and 48
    15,16 : Week 48 or end of treatment (EOT)
    17 : Baseline to week 12, 24, and 48
    18 : Baseline to week 24, and 48
    19 : Baseline up to 68 weeks
    20,21 : Baseline up to week 68.; 1,2,5,6 : dal basale nel corso delle settimane 24 -48
    3,4 : dal basale alla settimana 24
    7 : dal basale alla settimana 4, 8, 12, 16, 20, 28, 32, 36, 40, 44 e 48
    8 : dal basale alla settimana 4, 12, 24 e 48
    9 : dal basale alla settimana 4, 8, 24 e 48
    10, 11, 12, 13, 14 : dal basale alla settimana 4, 12, 24, 36 e 48
    15,16 : Settimana 48 o fine del trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Chile
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    Ukraine
    United States
    Italy
    Poland
    Spain
    Czechia
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 974
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 146
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 1120
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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